Recall Z-1441-2013— Optovue, Inc.
Class III · Terminated
Class III FDA medical device recall by Optovue, Inc., initiated 2013-05-14, terminated 2013-10-24. It names one FDA 510(k) clearance: K121739. Product: Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.. Reason: Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports..
- Recalling firm
- Optovue, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-05-14
- Terminated
- 2013-10-24
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Reason for recall
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Data sourced from openFDA. This site is unofficial and independent of the FDA.